Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

Catalent Says It's Not Our Facility; It Belongs To Novo Nordisk

The FDA informed us again in April that the Bloomington, Indiana, facilities owned by Catalent until sold to Novo Nordisk in December 2024, have not solved quality issues. This adds to an FDA inspection/poor response and remediation history years long in the making. How is it we are witnessing this at a U.S. facility run by a name-brand CDMO and then Big Pharma? Catalent, for its part, wants to stop "inaccuracies in media coverage." Here's analysis from an experienced pharma professional and our own Chief Editor Louis Garguilo.

GUEST COLUMNISTS

July 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
ADC CDMO Selection For Small Biotech
Manufacturing is a critical factor in ADC success. Discover how to align CDMO capabilities with molecule complexity, mitigate risks, and navigate capacity limits.
Europe's ATMP Opportunity Still Requires Local Navigation
European nations offer a welcoming environment for clinical-phase cell and gene therapies. Don't assume the same flexibility carries through to commercialization.
The Unspoken Truth About Cell Therapy Product Understanding
Developers often discover important attributes after it's too late to act on them. A well-designed program asks what's needed for commercialization and works backward.
Implementing And Optimizing Your eQMS
This article addresses everything that follows the signed contract for an eQMS: how a system is configured, validated, adopted, and maintained.
Rebuilding America's Pharmaceutical Backbone Through Small-Batch Manufacturing
Many small molecule products no longer require massive production. Instead, flexible capacity is needed that can economically produce smaller commercial volumes while maintaining quality and compliance.
CDMO Selection For Small Biotech: Amit Jain On Avoiding Costly Transfers
Make smarter outsourcing decisions early. Reduce the risk of costly tech transfers, evaluate capacity needs, speed development timelines, and strengthen manufacturing partnerships.
The Complex Anatomy Of An ADC Tech Transfer
Unlike traditional biologics tech transfer, antibody-drug conjugates have many more moving parts. Here are some of the unique challenges that require close attention.

PHARMA OUTSOURCING WHITE PAPERS

How Lipid Nanoparticles Enable Next-Gen Delivery
Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.

Empowering Antibody Discovery With ProSpeed™
Integrating linear expression technology into single B cell workflows accelerates antibody discovery, enabling early functional screening, improved sensitivity, and cost-effective identification of diverse therapeutic candidates.
Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes
The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.
ADC Development Grows More Complex — SPR Insights Bring Clarity
Explore how real-time kinetic analysis reveals how conjugation, linker chemistry, and drug loading influence antibody–antigen interactions, while enabling sensitive detection of anti-drug antibodies.
Redefining The Analytical Frameworks Surrounding Capsid Characterization
Modern AAV manufacturing demands precise capsid characterization to distinguish empty, partial, and full particles, as regulators now require rigorous purity and potency control for clinical safety.
Performance Characteristics Of The Mobius® ADC Reactor For Conjugation
Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.